510(k) K232797
K232797 is an FDA 510(k) premarket notification submitted by Shenzhen Hygenix Industrial Co., Ltd. for the device "Hygenix". The FDA issued a decision of Substantially Equivalent on December 11, 2023. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 2023
- Date Received
- September 12, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mask, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type